Philips Ingenia 3.0T MRI Scanner Tabletop Blockage Risk
Philips is recalling 33 Ingenia 3.0T MRI scanners whose Integrated Radio Frequency Carrier assembly screws may come loose and block the horizontal tabletop, potentially causing diagnostic delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a potential risk-of-harm hazard: loose screws could interfere with scanner operation and block the tabletop, causing diagnostic delays and patient distress. No injuries or illnesses have been reported.
Plain-English summary
Philips North America LLC is recalling 33 units of the Ingenia 3.0T MRI diagnostic scanner. The device produces cross-sectional and spectroscopic images of the body for medical diagnosis. This recall involves specific serial numbers documented by the manufacturer.
The Integrated Radio Frequency (IRF) Carrier assembly in these devices may contain screws that come loose and protrude beyond their intended surface. These loose screws could interfere with other moving components of the scanner, potentially blocking the horizontal tabletop on which patients are positioned.
If the tabletop becomes blocked during scanning, patients may experience delays in receiving diagnostic images. Additionally, patients positioned inside the scanner bore for longer than expected durations may experience anxiety. The affected devices have been distributed worldwide to medical facilities in the United States and numerous other countries.
The recalled product
- Product
- Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
- Manufacturer
- Philips North America Llc
- Affected units
- 33
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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